Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03793205
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Brief Summary:
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Myelosuppression Adult Febrile Neutropenia Chemotherapy-induced Neutropenia Drug: Long-acting G-CSF Drug: Short-acting G-CSF Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Long-acting G-CSF group
Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
Drug: Long-acting G-CSF
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.

Experimental: Short-acting G-CSF group
Patients in long-acting G-CSF group only accept short-acting G-CSF.
Drug: Short-acting G-CSF
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.




Primary Outcome Measures :
  1. Incidence of febrile neutropenia [ Time Frame: One year ]
    Incidence of febrile neutropenia in each course


Secondary Outcome Measures :
  1. Incidences of grade 3/4 myelosuppression [ Time Frame: One year ]
    Incidences of grade 3/4 myelosuppression in each course

  2. Times of visits to outpatient and emergency clinics [ Time Frame: One year ]
    Visits to outpatient and emergency clinics in each course

  3. Doses of G-CSF [ Time Frame: One year ]
    Doses of G-CSF administrated in each course



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed primary gynecologic cancer
  • Good performance status
  • Aged 18 years or older
  • Signed an approved informed consents
  • No immunosuppressive disease

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793205


Contacts
Layout table for location contacts
Contact: Lei Li +8613911988831 lileigh@163.com

Locations
Layout table for location information
China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li

Layout table for additonal information
Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03793205     History of Changes
Other Study ID Numbers: GO-GCSF
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs